(123 days)
The Distal Radius Plate System is designed for internal fixation of the distal radius. The distal radius plates are available in left and right volar configurations and in two sizes, small and large.
The Humerus Plate System is designed for internal fixation of the proximal humerus. The humerus plates are available in right and left configurations and in three hole and five hole length.
Cortical and cancellous bone screws are required to secure the plates to the bone. A variety of screw are available for this application in order to accommodate different fracture types and locations, bone density and surgeon preference.
The ACE Humerus Plates and Radius Plates are anatomically contoured bone plates which are attached to the bone with cortical or cancellous bone screws. The humerus plates will offered in two configurations for both the left side and the right side. The plates are offered in three hole and five hole configurations.
The ACE Radius plates are also offered in a right and left configuration both for volar fixation and dorsal fixation. The plates are offered in a large and a small size.
Here's an analysis of the provided information, focusing on acceptance criteria, study details, and ground truth establishment:
Disclaimer: Based on the provided text, the device is a medical implant (bone plates) and not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested categories related to AI performance, ground truth establishment for AI, and MRMC studies are not applicable. I will provide information relevant to the provided text for a physical medical device.
Acceptance Criteria and Device Performance (Based on Physical Device Testing)
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance (ACE Upper Extremity Plates) |
|---|---|---|
| Mechanical Strength | Comparable static bending strength to predicate devices. | "The ACE Plates were comparable in bending strength to the predicate device" |
| Biocompatibility | Manufactured from a biocompatible material commonly used in orthopedics. | "manufactured of a biocompatable titanium alloy, commonly used in the orthopedic industry." |
| Intended Use | Suitable for internal fixation of the distal radius and proximal humerus. | "designed for internal fixation of the distal radius" and "designed for internal fixation of the proximal humerus." |
Study Details (Applicable to Physical Device Testing)
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the exact number of plates tested. It mentions "Three types of plates (proximal humerus, volar distal radius and dorsal distal radius) were tested," implying at least one sample of each type. It's likely more than one per type were tested for statistical validity, but this is not explicitly stated.
- Data Provenance: Not explicitly stated. This was a laboratory study conducted by Ace Medical Company or a contracted lab. There is no mention of "clinical data" or "patient data," indicating it was a benchtop mechanistic test.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a physical device's mechanical testing, "ground truth" is typically established by engineering standards and measurement accuracy, not expert consensus.
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Adjudication method for the test set: Not applicable. This refers to consensus among experts, which is not relevant for benchtop mechanical testing. Results are typically determined by measurement and adherence to predefined engineering specifications or comparison thresholds.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This study refers to an AI/Software as a Medical Device (SaMD), not a physical orthopedic implant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to an AI/Software as a Medical Device (SaMD).
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The type of ground truth used: For mechanical testing, the "ground truth" is defined by established engineering principles and the performance of predicate devices. The study compared the static bending strength of ACE plates to predicate devices (Synthes and DePuy plates). Therefore, the "ground truth" for performance was the established mechanical properties of these legally marketed, equivalent devices.
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The sample size for the training set: Not applicable. This refers to an AI/Software as a Medical Device (SaMD). The design and development of physical implants do not typically involve "training sets" in the AI sense.
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How the ground truth for the training set was established: Not applicable. This refers to an AI/Software as a Medical Device (SaMD).
Summary of Non-Applicable Sections for a Physical Device:
The provided text describes a submission for physical bone plates, not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested items related to AI device performance evaluation, such as:
- Sample size for the training set
- How ground truth for the training set was established
- Number of experts for ground truth
- Adjudication method for experts
- MRMC comparative effectiveness study
- Standalone algorithm performance
...are not applicable to this 510(k) summary. The study described focuses on benchtop mechanical testing to demonstrate substantial equivalence to predicate devices, a standard practice for physical orthopedic implants.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.